Certainly, a smile came across my face when I first saw this. Even the most equipoised palliative care practitioner must have done the same (feel free to let us know if you didn't). The implications of this study, a randomized control trial of early palliative care in patients with stage IV non-small cell lung cancer published in the New England Journal of Medicine, will not be fully revealed for a while, but are likely to be important and long-lasting. The primary outcomes of the study stand on their own as important--it's yet more evidence that palliative care interventions improve quality of life and reduce psychological morbidity. The headlines from above derive from the secondary outcomes of the study--that palliative care may improve survival while reducing morbidity.

Before I write anything else about the study, I'll direct you to the editorial by Amy Kelley and Diane Meier.

The study was a single institution trial at Massachusetts General Hospital. Patients were randomized to receive either usual care or early palliative care integrated into oncologic care. The study intervention consisted of monthly outpatient palliative care visits (by a physician or nurse practitioner) until death with an average of four visits in the first 12 weeks. Control patients received usual care and only saw palliative care if requested by the oncologist with 14 percent of control patients receiving a palliative care evaluation. The two groups were similar in several demographic, prognostic, disease specific factors (including EGFR status of the cancer!), and QOL/mood measurements.

The primary outcome was a statistically significant reduction the Trial of Outcome Index (TOI) in the study group vs. the control group at 12 weeks. The TOI is a sum of the physical well-being and functional well-being subscales of the Functional Assessment of Cancer Therapy–Lung (FACT-L) and the the lung-cancer subscale (LCS) of the FACT-L scale evaluates seven symptoms specific to lung cancer. The study group also had a lower incidence of depression at 12 weeks but similar incidence of anxiety.

The secondary outcomes included utilization of health care near the end of life. The study was not powered to detect differences in utilization, however, there was a trend towards reduced chemotherapy utilization, hospitalization, emergency department visits, and an increase in hospice utilization and rate of death at home or an inpatient hospice facility.

And the one-liner that is garnering all the attention:

Despite receiving less aggressive end-of-life care, patients in the palliative care group had significantly longer survival than those in the standard care group (median survival, 11.6 vs. 8.9 months; P=0.02)

This study strikes at the heart of two important misconceptions that may lead to underutilization of palliative care services:

Primary providers (e.g. oncologists) who suggest that they "already do this" and that there is no benefit to additional services. I think the primary outcomes of the study are pretty airtight and consistent with past non-controlled studies that suggest benefit of palliative care interventions. Could oncologists provide these services and achieve the same outcomes? Hard to say since the intervention is bundled. Perhaps there are discrete parts of the intervention that an oncologist could deliver which would lead to the same outcomes, and certainly there is reason to believe that how oncologists do their job influences the outcomes studied. However, the lens through which palliative care physicians see patients is inherently different from the lens of the oncologist. While one might be able to borrow the other's lens momentarily, it's conceivable that due to the complexity of advanced medical illness, there's value in both being on hand regardless of how oncologists are trained or reimbursed.

That palliative care equals "giving up." As the authors and editorialists state, the survival result needs to be replicated in further studies. There is evidence of lesser quality to suggest that other components of palliative care may lengthen life (for instance, hospice and morphine) so this secondary result should not be too surprising. The mechanism of this possible effect is quite unclear. Perhaps it's through excellent symptom control or perhaps through avoidance of toxic chemotherapy in an already failing organism. Regardless, it can be safely concluded from this study that the palliative care service at Mass General is NOT the grim reaper and may be quite the opposite, on the magnitude of Sorafenib for hepatocellular cancer. (*Fettig puts away his grim reaper costume and puts on his sorafenib cape, the new symbol of palliative care glory...well, I admit I don't work with the Mass General Palliative Care team, so cannot say that this study generalizes to my care, but I'm at least hopeful. Okay, I don't own and don't want a Sorafenib cape.*)

Some other points:

This is primarily an outpatient intervention. Palliative care has grown up inside the walls of the hospital, but palliative care outpatient services are growing. Time to grow more.

I think it might be time to phase out the below diagram- perhaps it helps illustrate the difference between hospice in the US and palliative care, but may not represent the state of the art palliative care intervention as reflected in this study (better if provided early, often, and throughout the course of the disease).

Does this study represent the gold standard for a palliative care health services RCT? Likely. It's the inverse of an excellent chemotherapy trial where the primary outcome may relate to survival but where strong secondary QOL outcomes are examined.

The methods in this study could be applied to many different patient populations, both oncologic and non-oncologic. "New diagnosis of Stage IV lung cancer" represents a trigger (I know some dislike that word, but it's the best I got). What other outpatient triggers could you envision? HIV with low CD4 count chronically and a recent admission for opportunistic infection? Childs class C cirrhosis with (choose your own other variable)? Non-small cell lung cancer is a neat and tidy place to start for this type of study- it's the most common diagnosis that I see (and I suspect many of you too), the prognosis is good enough that you can follow patients for several months but not for years. This makes the study and the intervention doable.

Related to the last point, how can we work towards bundling this type of intervention back into primary care, have it reimbursed, and provide appropriate training for future clinicians so that they can do the bulk of this work? The Holy Grail. Your job is (relatively) safe.

As noted above and in the discussion section of the article, this study was done at a single tertiary academic institution and may not be applicable to all settings. I would very much like to know more about how this intervention was structured (down to the logistics of the clinic, timing of seeing patients in relation to the oncologist, other interdisciplinary team member involvement, etc) (Edit: Please see the Appendix of the NEJM study for more details regarding the intervention.) While it's possible that this intervention might not work in some settings, it's also conceivable that an excellent palliative care service at a non-academic setting may fare even better. Time for more research!

Pallimed: A Hospice & Palliative Medicine Blog Founded June 8, 2005.
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